The Clinical Protocol, Data Management and Informatics (CPDMI) Shared Resource administrates clinical oncology research at the University of New Mexico (UNM) Cancer Center under the supervision of the Clinical Research Committee. The Medical Director of the CPDMI is D. Jones, who has extensive experience in clinical oncology research, and the Executive Director is T. Stewart. This Shared Resource has a current budget (FY2008/9) of $1.3 million. The CPDMI consists of 1 Medical Director, 1 Executive Director, 1 Regulatory Manager, 1 Quality Assurance Manager, 1 Database Administrator, 4 regulatory coordinators, 2 administrative assistants, 1 human protection specialists, and 1 Program Manager/accountant. The CPDMI includes a clinical informatics effort led by Kroth, which has 4 FTE, and a clinical trials imaging effort led by Eberhardt. The major goal of this Shared Resource is to provide support of the clinical trial process, including implementing and regulating trials, and providing a centralized clinical trial database, investigational pharmacy support, financial accounting, data safety monitoring, and quality assurance. This Shared Resource also assists physician investigators in the design and subsequent conduct of clinical trials. It performs all regulatory reporting and quality assurance needed to comply with Good Clinical Practice in the performance of clinical trials. The CPDMI has created Standardized Operating Procedures for all its activities, including training of all new faculty and staff. In FY2008/9, the CPDMI Shared Resource administrated 327 Cancer Center protocols, of which 114 were therapeutic/interventional trials. These therapeutic trials are also open within the New Mexico Cancer Care Alliance, the consortium of community oncologists affiliated with the UNM Cancer Center. At UNM Cancer Center outpatient clinics, 2640 new cancer patients (Summary 3) were treated in fiscal year 2009, and there were 443 accruals to therapeutic trials (17% of new patients), with an additional 101 therapeutic accruals supervised by the CPDMI at the Alliance affiliate sites. Accruals to all types of trials using the CPDMI were 1241 in fiscal year 2009. Of patients accrued to therapeutic clinical trials, 83% were women, 7% were Native Americans, and 44% were Hispanics. The UNM Cancer Center patient population had 56% women, 11% Native Americans, and 34% Hispanics. Additionally, the CPDMI reviewed 137 subject records as part of internal audits at UNM Cancer Center and affiliate sites.

Public Health Relevance

A major goal of the UNM Cancer Center is to develop new treatments for cancer patients. These new treatments must be tested using clinical research. This Shared Resource is responsible for administrating the clinical trials of the UNM Cancer Center. This administration of the clinical research enterprise implements and regulates clinical trials, and provides a centralized clinical trial database, investigational pharmacy support, financial accounting, data safety monitoring, and quality assurance. These elements are essential for testing new cancer treatments.